What is FDA product code FDA?

To provide visualization and perform various procedures within the small intestine. For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

Gastroenterology & Urology › DiagnosticEnteroscope And Accessories

Endoscope Position Detecting Unit

Name: Endoscope Position Detecting Unit
Brand: Endoscope Position Detecting Unit

2 catalogue numbers from UPD-3, listed by Olympus Medical Systems Corp., Japan, under Enteroscope And Accessories. 1 manufacturer in China is registered for this product code.

Registry build 21.09.26

1manufacturer

2catalogue numbers in this listing

1510(k) clearance

Who Else Makes It

Registered in Liaoning. One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code FDA
Manufacturer	City	Province	Registered as	Device types
Dalian Create Medical Products Co., Ltd.	Dalian	Liaoning	Contract manufacturer	2

Record

Regulatory record for Endoscope Position Detecting Unit
Listed by	Olympus Medical Systems Corp., Japan
FDA product code	FDA
Device type	Enteroscope And Accessories
Device class	Class 2
Regulation	21 CFR 876.1500
Establishment	Specification developer, Manufacturer, Exporter
Record published	2016-09-21
Record revised	2023-01-16 (version 6)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Label carries	manufacturing date, serial number
Distribution end date	2022-08-15

Catalogue Numbers

Catalogue numbers for Endoscope Position Detecting Unit
Catalogue number	Size	Status
UPD-3		In distribution
UPD-3		Withdrawn

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Fujifilm	Fujifilm Corporation	6
Cardinal Health	Cardinal Health 200, LLC	2
Balloon Control Unit	Olympus Medical Systems Corp.	2
Q Urological Persistent Aguamedicina	Q Urological Corporation	2
Evis Exera II Small Intestinal Videoscope	Olympus Medical Systems Corp.	2
CD138 + Cyclin D1	Biocare Medical, LLC	1
HealthMart	Strategic Sourcing Services LLC	1
TG-98 LM Synea 400	W&H Dentalwerk Bürmoos GmbH	1
Ancora	Aspero Medical, Inc.	1
Zeus-P	Spinal Elements, Inc.	1
Jade PTA Balloon Dilatation Catheter	OrbusNeich Medical (Shenzhen) Co., Ltd.	1
Premier Jackson Improved Short Tracheostomy Tube	Premier Dental Products Co.	1

Showing 12 of 19. All products under Enteroscope And Accessories

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K071254	2008-03-25

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.